The Manager, Healthcare Compliance will assist with the implementation of a global compliance and ethics program covering commercial activities, including the implementation of systems, programs, processes, and practices to ensure that all business units are in compliance with legal and regulatory requirements. The Manager, Healthcare Compliance will manage Compliance Investigations and the Investigations Database. In addition, the Manager, Healthcare Compliance will maintain and update - as necessary - the Healthcare Compliance policies and procedures as well as the Legal/Compliance cabinet within Master Control. The Manager, Healthcare Compliance will assist with the creation and deployment of compliance training and with implementing a compliance auditing and monitoring plan designed to mitigate risk and support auditing and monitoring activities. The Manager, Healthcare Compliance will prepare updates, presentations, and compliance reports for executive management, as necessary.
The Manager, Healthcare Compliance will report to the Chief Compliance Officer
- Support the Compliance department with daily compliance requirements, including conducting debarment checks, FMV analyses and Ad Board approvals.
- Assist with the creation of processes and policies to support the Compliance Program. Maintain the Legal/Compliance's policy cabinet in Master Control as well as Policy Center on the company's Intranet page.
- Manage Intercept's Compliance Investigations and maintain Intercept's Investigations Database.
- Support creation and implementation of Compliance communications.
- Assist with the implementation of the Compliance Training Program.
- Assist with the execution of the Compliance department's monitoring and auditing program.
- Other duties as assigned.
- Strong verbal and written communication skills are essential.
- Excellent organization and multi-tasking skills.
- Exceptional interpersonal skills and problem solving capabilities.
- Proven negotiation skills.
- Ability to work effectively across a matrix organization.
- Ability to work independently and prioritize with minimal daily instruction.
- Ability to think strategically in order to improve current processes.
Experience and Skills
- Bachelor's degree in a science related field or equivalent with experience in a biopharmaceutical environment. Experience in a commercial entity is a must.
- Minimum of 5-7 years prior work experience, preferably at a global pharmaceutical company.
- High-level of familiarity with a broad range of compliance risk areas, in particular relating to commercial practice of a global biopharmaceutical company.
- Knowledge of compliance regulations and industry guidance, such as Anti-Kickback, False Claims Act, Foreign Corrupt Practices Act, UK Anti-Bribery, Sunshine and transparency laws, PhRMA Code, EFPIA Code, ABPI Code and similar laws, regulations and industry standards in the United States and Europe.
- Excellent interpersonal, communication and written skills, proven ability to work with a wide range of stakeholders, including internal personnel from a number of countries and cultures.
- Strong presentation and training skills and ability to work independently and build strong networks throughout the organization.
- Ability to effectively work with and manage a number of vendors supporting the Company's compliance efforts across the world.
- Interact with Senior management, employees at all levels, vendors and customers.
- Up to 30% travel may be required.